A First Human Dose Trial Investigating Safety, Tolerability and Pharmacokinetics for Single Doses and Multiple Doses of NNC0165-1562 in Overweight to Obese But Otherwise Healthy Subjects

A First Human Dose Trial Investigating Safety, Tolerability and Pharmacokinetics for Single Doses and Multiple Doses of NNC0165-1562 in Overweight to Obese But Otherwise Healthy Subjects.

This trial is conducted in the United States of America. The aim of the trial is to investigate safety, tolerability and pharmacokinetics (the exposure of the trial drug in the body) for single doses and multiple doses of NNC0165-1562 in overweight to obese but otherwise healthy subjects.

Study Overview

• Status: Completed
• Conditions: Obesity; Metabolism and Nutrition Disorder
• Intervention / Treatment: Drug: NNC0165-1562; Drug: placebo

• Study Type: Interventional
• Enrollment (Actual): 93
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tempe, Arizona, United States, 85283
      • Novo Nordisk Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Part I (SD):
• Male, aged 18-55 years (both inclusive) at the time of signing informed consent
• Body mass index (BMI) between 25.0 and 34.9 kg/m^2 (both inclusive). Overweight should be due to excess of adipose tissue, as judged by the investigator
• Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram (ECG) and clinical laboratory tests performed during the screening visit, as judged by the investigator
• Part II (MD):
• Male or female, aged 18-55 years (both inclusive) at the time of signing informed consent
• Body mass index (BMI) between 27.0 and 39.9 kg/m^2 (both inclusive). Overweight should be due to excess of adipose tissue, as judged by the investigator
• Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram (ECG) and clinical laboratory tests performed during the screening visit, as judged by the investigator

Exclusion Criteria:

• Any clinically significant weight change (at least 5% self-reported change during the previous 3 months), dieting attempts (e.g. participation in an organised weight reduction programme within the last 3 months), prior obesity surgery, or medications affecting body weight within 3 months prior to screening
• Male subjects who are not surgically sterilised (vasectomy) and are sexually active with female partner(s) who are not using a highly effective method of contraception (such as condom with spermicide) combined with a highly effective method of contraception for their non-pregnant female partner(s) (Pearl Index 1%, such as implants, injectables, oral contraceptives, intrauterine devices, diaphragm or cervical cap+spermicide), and/or intend to donate sperm in the period from screening until 3 months following administration of the investigational medical product
• Female subjects who are of child bearing potential (pre-menopausal and not surgically sterilised) and are sexually active with male partner(s) who are not surgically sterilised (vasectomy) and are not using highly effective contraceptive methods (Pearl Index 1%,such as implants, injectables, oral contraceptives, intrauterine devices, diaphragm or cervical cap+spermicide) combined with a highly effective method of contraception for their male partner(s) (e.g. condom with spermicide), and/or are pregnant, breast-feeding or intend to become pregnant) (applicable to Part II (MD) only)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: placebo; Administered subcutaneously (s.c., under the skin) single dose [SD]) or multiple dose [MD] with daily dosing.
Experimental: NNC0165-1562	Drug: NNC0165-1562; Administered subcutaneously (s.c., under the skin) single dose [SD] or multiple dose [MD] with daily dosing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of treatment emergent adverse events (TEAEs), Part I (SD)	From time of dosing (Day1) until completion of the follow-up visit (Day 29)
Number of TEAEs, Part II (MD)	From time of dosing (Day 1) until completion of the follow-up visit (Day 85)

Secondary Outcome Measures

Outcome Measure	Time Frame
The area under the NNC0165-1562 plasma concentration-time curve, Part I (SD)	From time 0 to 24 hours after a single s.c. dose. From baseline (Day 1) until the follow-up visit (Day 29)
The maximum plasma concentration of NNC0165-1562 after a single s.c. dose, Part I (SD)	From baseline (Day 1) until the follow-up visit (Day 29)
The time to maximum plasma concentration of NNC0165-1562 after a single s.c.dose, Part I (SD)	From baseline (Day 1) until the follow-up visit (Day 29)
The area under the NNC0165-1562 plasma concentration-time curve, Part II (MD)	From time 0 to 24 hours at steady state. From baseline (Day 1) until the follow-up visit (Day 85)
The maximum plasma concentration of NNC0165-1562 at steady state, Part II (MD)	From baseline (Day 1) until the follow-up visit (Day 85)
The time to maximum plasma concentration of NNC0165-1562 at steady state, Part II (MD)	From baseline (Day 1) until the follow-up visit (Day 85)

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S

Publications and helpful links

Helpful Links

• Clinical Trials at Novo Nordisk

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2015
• Primary Completion (Actual): February 7, 2017
• Study Completion (Actual): February 7, 2017

Study Registration Dates

• First Submitted: October 2, 2015
• First Submitted That Met QC Criteria: October 2, 2015
• First Posted (Estimate): October 5, 2015

Study Record Updates

• Last Update Posted (Actual): July 13, 2018
• Last Update Submitted That Met QC Criteria: July 12, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Overweight; Nutrition Disorders
• Other Study ID Numbers: NN9747-4194; U1111-1164-6546 (Other Identifier: WHO)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes